Field of the Invention
The present invention relates to a closed circuit sterile device and method of collection, transport and processing in total sterile chain.
More specifically, the invention concerns a medical-surgical sterile device, suitable for collecting and transporting from the surgery room to the clinical and microbiological analysis laboratory of human biological samples (body fluids, tissues, organs and portions thereof) and/or implantable or explanted prosthetic materials during surgeries (such as, by way of example, but not limited thereto, joint replacements or their parts or components, metal plates, wires, cerclage, screws, nails, staples, bone cement, bone substitutes, catheters, heart valves, breast implants, urological implants, neurosurgical implants and osteosynthesis materials, dentures or maxillofacial prostheses, etc.), so as to totally preserve them from bacterial contamination.
In the following, the description will be directed to the collection and the transport of an explanted prosthesis or biological samples, but it is clear that it must not be considered limited to these specific uses.
Brief Discussion of the Related Art
As it is well known, at present the market for implanted biomaterials, in particular directed to the orthopedics and traumatology medical fields, is presenting a very high development, due to the number of patients steadily increasing.
It is also well known that bacterial infections related to the installation or the removal of such biomaterials are the most dangerous complication in said orthopedics and traumatology fields, with their associated high social and economic costs.
Bacterial infection is, then, in any case, a very dangerous complication also in the fields of neurosurgery, in cardiovascular medicine, in urology, in plastic surgery and in general surgery.
The detection of bacteria, when carried out, for example, on human biological samples (biological fluids, tissues, organs and portions thereof) and/or implantable materials or prosthetic explanted during of surgical procedures (e.g., but not limited thereto, joint replacements or their parts or components, metal plates, wires, cerclage, screws, nails, staples, bone cement, bone substitutes, catheters, heart valves, breast implants, urological implants, neurosurgical implants and osteosynthesis materials, dentures or maxillofacial prostheses, etc.) is also essential to confirm any diagnosis, as well as to allow, therefore, the determination of the most appropriate antibiotic treatment, which, in such cases, can even extend for several weeks or months.
Generally, to detect any bacteria, for example in an explanted prosthesis, it has to be transported in a suitable analysis laboratory, away from the surgery room, by means of a sterile container, to be extracted out of the container, once arrived at the laboratory analysis, and performing, thus, the analysis operations.
To extract bacteria from prostheses different processes are known. A first process is known as sonication, and it uses a mechanical instrument to remove bacteria from the implants or prostheses. That system is effective to increase the rate of isolation of the bacterial biofilm. However, such technology is rather long in the application, as well as expensive, as it requires specially trained personnel. These limits imply the use only in a reduced number of hospitals.
Recently it has been proposed and developed a system of chemical detachment of bacteria from prosthetic implants in vitro. This technique is effective as the sonication, but it has a low cost and a remarkable ease of use. Such chemical extraction is obtained by treating the biomaterial implanted with a dithiothreitol (DTT) solution.
As it is easy to understand, the main risk of bacterial detection procedures is that the prosthesis or the biological material to be collected for the examination is contaminated during the transport phase or the extraction of the same from the container intended to protect and transport the same, since, in that case, there would be a so called “false positive”, i.e. a prosthesis contaminated by bacteria not of the surgical site (i.e. by those bacteria which existence is really desired to detect), but exogenous. This could lead a patient to be subjected to a preventive antibiotic treatment, without a real need.
It appears evident that this procedure is subject to high risks for the patient.
The patent application US2010/261157 A1, U.S. Pat. No. 3,163,160 A and U.S. Pat. No. 5,869,003 A are known in the art.
The first patent application relates to a container having two compartments, separated by a barrier, in one of which a swab can be inserted and in the other there is a processing fluid. The swab may be inserted in the other compartment, for obtaining a sample to be analyzed. The problem of the described solution is that it does not allow multiple withdrawals of the solution without contamination risk.
The patent application U.S. Pat. No. 3,163,160 A is a system similar to the previous one, but in this case it is the processing liquid that passes into the compartment in which the swab is placed. Also in this case, it is not possible to perform with certainty multiple withdrawals of the solution without risk of contamination.
Finally, the patent application U.S. Pat. No. 5,869,003 A relates to a diagnostic kit, which comprises a material strip with diagnostic reagent, that when contacting a swab in a sterile compartment, allows to detect the infection status of the biological material on the swab.